Trial Outcomes & Findings for A Multi-Center Study of the Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival (NCT NCT01996826)

NCT ID: NCT01996826

Last Updated: 2020-08-10

Results Overview

Endothelial rejection rates in patients in the treatment group and the control group were calculated using the Kaplan-Meier survival curve. The Kaplan-Meier/product limit estimator is a non-parametric statistical test used to show the probability of an event occurring at a given time interval. The Kaplan-Meier estimator is used to show what the probability of corneal transplant rejection (and therefore transplant survival) after administration of the active treatment or control.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 75 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2020-08-10

Participant Flow

Participant milestones

Measure	Avastin® (Bevacizumab) Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.	0.9% NaCl & Refresh Liquigel Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. 0.9% NaCl \& Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks.
Overall Study STARTED	39	36
Overall Study COMPLETED	32	33
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Measure	Avastin® (Bevacizumab) Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.	0.9% NaCl & Refresh Liquigel Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. 0.9% NaCl \& Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks.
Overall Study Lost to Follow-up	6	2
Overall Study Physician Decision	1	1

Baseline Characteristics

A Multi-Center Study of the Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival

Baseline characteristics by cohort

Measure	Avastin® (Bevacizumab) n=39 Participants Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.	0.9% NaCl & Refresh Liquigel n=36 Participants Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. 0.9% NaCl \& Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks.	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Age, Continuous	63.5 years STANDARD_DEVIATION 13.9 • n=5 Participants	65.4 years STANDARD_DEVIATION 16.0 • n=7 Participants	65 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	36 participants n=7 Participants	74 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Endothelial rejection rates in patients in the treatment group and the control group were calculated using the Kaplan-Meier survival curve. The Kaplan-Meier/product limit estimator is a non-parametric statistical test used to show the probability of an event occurring at a given time interval. The Kaplan-Meier estimator is used to show what the probability of corneal transplant rejection (and therefore transplant survival) after administration of the active treatment or control.

Outcome measures

Measure	Avastin® (Bevacizumab) n=36 Participants Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.	0.9% NaCl & Refresh Liquigel n=36 Participants Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. 0.9% NaCl \& Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks.
Endothelial Rejection Rate	2 Participants	5 Participants

PRIMARY outcome

Timeframe: 12 months

Incidence and severity of ocular adverse events during the study (based on ophthalmic examination and subject self-reporting).

Outcome measures

Measure	Avastin® (Bevacizumab) n=36 Participants Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.	0.9% NaCl & Refresh Liquigel n=36 Participants Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. 0.9% NaCl \& Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks.
Number of Participants Experiencing Ocular Adverse Events Incidence of Mild Ocular Adverse Events	21 Participants	21 Participants
Number of Participants Experiencing Ocular Adverse Events Incidence of Ocular Adverse Events	34 Participants	35 Participants
Number of Participants Experiencing Ocular Adverse Events Incidence of Moderate Ocular Adverse Events	8 Participants	8 Participants
Number of Participants Experiencing Ocular Adverse Events Incidence of Severe Ocular Adverse Events	4 Participants	6 Participants

PRIMARY outcome

Timeframe: 12 Months

Incidence and severity of systemic adverse events during the study (based on physical examination, subject self-reporting, and changes in vital sign).

Outcome measures

Measure	Avastin® (Bevacizumab) n=36 Participants Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.	0.9% NaCl & Refresh Liquigel n=36 Participants Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. 0.9% NaCl \& Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks.
Incidence of Systemic Adverse Events Incidence of Systemic Adverse Events	34 Participants	36 Participants
Incidence of Systemic Adverse Events Incidence of Mild Systemic Adverse Events	10 Participants	6 Participants
Incidence of Systemic Adverse Events Incidence of Moderate Systemic Adverse Events	2 Participants	1 Participants
Incidence of Systemic Adverse Events Incidence of Severe Systemic Adverse Events	2 Participants	1 Participants

Adverse Events

Avastin® (Bevacizumab)

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

0.9% NaCl & Refresh Liquigel

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	Avastin® (Bevacizumab) n=39 participants at risk Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.	0.9% NaCl & Refresh Liquigel n=36 participants at risk Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. 0.9% NaCl \& Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks.
Cardiac disorders Atrial fibrillation (subject was hospitalized for 3 days)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Renal and urinary disorders Urinary Track Infection (subject hospitalized for 3 days)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Cardiac disorders congestive heart failure (subject hospitalized)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	5.6% 2/36 • Number of events 2 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Infections and infestations Pulmonary embolism	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Nervous system disorders a stroke	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.

Other adverse events

Measure	Avastin® (Bevacizumab) n=39 participants at risk Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.	0.9% NaCl & Refresh Liquigel n=36 participants at risk Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule. 0.9% NaCl \& Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks.
Eye disorders AC cells in study eye	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders AC cells (OS)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Acanthamoeba infection in study eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Acute graft edema	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Skin and subcutaneous tissue disorders Allergic reaction to Bacitracin	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Cardiac disorders Allergic reaction to medications prescribed for congestive heart failure	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Respiratory, thoracic and mediastinal disorders Asthma exacerbation	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders Back Pain	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Blurred vision (OD)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 2 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Blurry vision (OS)	2.6% 1/39 • Number of events 2 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	8.3% 3/36 • Number of events 5 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Blurry vision (OU)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Blurry vision in study eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	5.6% 2/36 • Number of events 2 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Blurry vision	12.8% 5/39 • Number of events 7 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Broken sutures (2 broken sutures)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Burning in study eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Central epithelial defect in study eye	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Central scotoma in OD (non-study eye)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Cloudy vision in study eye	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Cloudy vision	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Conjunctivitis	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Corneal edema (OS)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Corneal infiltrate near the suture	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Corneal Transplant	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Corneal ulcer	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Dark spot in central vision upon awakening each morning	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Darkening of vision (OD)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Decrease in vision	2.6% 1/39 • Number of events 2 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Decrease in vision following intravitreal injection of Eylea	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Descement's folds (OS)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Difficulty seeing (OU)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders Difficulty/pain with walking caused by recent arthritis	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Dimming of vision (OD)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Diplopia & glare at night when driving (OS)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Discomfort with tearing and burning	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Double vision (OU)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Dry eye	15.4% 6/39 • Number of events 7 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	8.3% 3/36 • Number of events 3 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Dry eye from allergies in study eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Ear and labyrinth disorders Ear wax in the ear causing pain in the ear and face	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders High intraocular pressure	10.3% 4/39 • Number of events 4 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	11.1% 4/36 • Number of events 5 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Low intraocular pressure	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Endothelial (Khodadoust) rejection	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders fungal infection in the OD	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Epithelial defect	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	8.3% 3/36 • Number of events 4 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Flashes	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	5.6% 2/36 • Number of events 3 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Floaters	5.1% 2/39 • Number of events 3 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	11.1% 4/36 • Number of events 4 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Floaters following a clinical laser procedure	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Floater following intravitreal injection of Eylea	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Foreign body sensation	64.1% 25/39 • Number of events 36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	41.7% 15/36 • Number of events 22 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Graft rejection	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	5.6% 2/36 • Number of events 2 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Green discharge in operative eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders Headache	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Headaches due to ocular pain	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders Herpes keratitis	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders High blood pressure	10.3% 4/39 • Number of events 7 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	8.3% 3/36 • Number of events 4 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders Hospitalization for shortness of breath with logs of edema in legs and fluid in lungs	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Increase in the frequency of stinging when instilling eye drops	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Infection from scleral lenses in non-study eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Cardiac disorders Irregular heartbeat	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Itchy eye	10.3% 4/39 • Number of events 4 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	5.6% 2/36 • Number of events 2 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Left periocular trauma with an electrical cord plug. No injury to the eye. No symptoms. Subject feel	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Eye lid pain	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Light sensitivity in study eye	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Mild irritation in the operative eye following a Lucentis injection	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Mild edema in graft	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Mild ptosis (OD)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders Nausea	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	5.6% 2/36 • Number of events 3 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Obscured vision in study eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Ocular pain	46.2% 18/39 • Number of events 23 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	25.0% 9/36 • Number of events 11 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Ocular ache/pain in outer corner of non-study eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Ocular pain the night of the surgery	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Ocular redness	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	5.6% 2/36 • Number of events 4 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders Patient was hospitalized for urinary track infection	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Patient went to ER for bronchitis	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Photophobia	35.9% 14/39 • Number of events 25 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	41.7% 15/36 • Number of events 24 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative ocular pain	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	8.3% 3/36 • Number of events 3 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative mild graft edema	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	8.3% 3/36 • Number of events 3 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative AC cells	5.1% 2/39 • Number of events 2 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	8.3% 3/36 • Number of events 3 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative stromal edema	7.7% 3/39 • Number of events 3 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative mild irritation and soreness	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative high intraocular pressure	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative aching/burning in study eye	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative epithelial defect	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	5.6% 2/36 • Number of events 2 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative tearing	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	5.6% 2/36 • Number of events 2 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative edema (3+)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative wound leak at clock hour 4	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative acid reflux	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative diffuse graft edema	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative increase in mucus in study eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative light sensitivity (OU)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative low Intaocular Pressure	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Post-operative iritis (OS)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Posterior Capsular Opacity (OS)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Possible rejection	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Punctate epithelial erosions (OS)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Retinal tear	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Ring of pink around the eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Retinal tear following a clinical laser procedure	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Retained lens cortex inferior (OS)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders Recurrent herpes keratitis	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Severe ocular pain	5.1% 2/39 • Number of events 2 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Stromal edema	5.1% 2/39 • Number of events 3 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	8.3% 3/36 • Number of events 3 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Stinging upon instillation	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Shortness of breath and swelling in leg	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders bruised eye	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders increase in back pain	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders scraped leg which became infected and resulted in debridement on July 20th.	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders graft failure	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders eye feeling heavier/tighter than usual	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders fever/flu with redness in eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders new scrape on leg	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders Subject visited podiatrist as toenail was falling off	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders "ping or a pluck" sensation	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders vision decreased	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders flashes of light	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders pain behind non-study eye	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders blood in stool	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders black strips in vision non-study eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders increase in leg cramps	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders urinary tract infection	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders seasonal allergies	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders hand surgery on his right hand	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders open blister on leg, which subject attributes to the CHF	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Sub-epithelial infiltrates	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders vertigo, light-headedness, and slight nausea	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
General disorders headache	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders seeing rust colors when looking at lights	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders left pupil appears to be smaller than right	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Superior neurocystic edema (OD)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Tearing	30.8% 12/39 • Number of events 19 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	47.2% 17/36 • Number of events 27 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Tenderness (OS)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Trichiatic lashes	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	5.6% 2/36 • Number of events 2 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Visual disturbances following a clinical laser procedure	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Wound leak	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Vitreous Hemorrhage	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Ocular discomfort	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Ocular burning upon instilling ophthalmic medication (Pred Forte and Vigamox)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Ocular burning upon using eye drops in study eye	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Ocular discomfort (OD)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Ocular hypertension	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Ocular discomfort when closing eyelids tightly (OS)	2.6% 1/39 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	0.00% 0/36 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.
Eye disorders Ocular eye irritation (OD)	0.00% 0/39 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.	2.8% 1/36 • Number of events 1 • 12 months All the subjects once enrolled into study were followed for the duration of the study (12 months) and examined for systematic and ocular adverse events at every study visit. Any adverse events that discovered by the study staff during the study visits were added to the Adverse Events Log. At every visit study subjects were also asked if any Adverse Events occurred in between study visits.

Additional Information

Reza Dana, M.D., M. Sc, MPH

Mass. Eye and Ear

Phone: 6175734331

Email: Reza_Dana@meei.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place